My Mobile Advice Program: A Randomized Pilot Feasibility Study (MyMAP)

Kaiser Permanente

Status: Completed

Conditions: Medication Adherence; Smoking Cessation

Treatments: Drug: Varenicline; Behavioral: MyMAP (My Mobile Advice Program); Behavioral: Cognitive-behavioral self-help

Study type: Interventional

Funder types: Other

Identifiers

NCT02136498

1R34DA034612

Details and patient eligibility

About

The purpose of this pilot study is to evaluate the acceptability and feasibility of the proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).

Full description

Investigators will develop and pilot test a prototype of the MyMAP intervention.The intervention is designed to help smokers better manage issues known to reduce treatment adherence (withdrawal symptoms, medication side-effects, low motivation, and inadequate behavioral skills for medication adherence) and to facilitate greater communication between patients and providers so clinicians can provide appropriate oversight of medication use, intervene when medically necessary, and address patient concerns that may otherwise lead to non-adherence or early treatment termination.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• An invited member of Group Health, a health care system in the Pacific Northwest
• Plan to remain enrolled in Group Health for the next 6 months
• aged 18 - 65
• Eligible for smoking cessation treatment through Group Health insurance coverage
• smoke >= 10 cigs a day
• speak and read in English
• willing to use varenicline and no contraindications for this medication
• ready to quit smoking
• have a smart phone with internet access
• willing to receive study texts and emails
• receive care at a Group Health clinic and have electronic medical records in this system
• fill prescriptions through the Group Health pharmacy
• agree to use birth control while taking study medication, if there is a risk of pregnancy

Exclusion criteria

• lifetime history of dementia
• psychosis or bipolar disorder based on self-report or medical record review
• hearing, comprehension or visual limitations that preclude full study participation
• current use of other forms of tobacco
• any medical contraindication for varenicline use
• documented history of suicidal ideation/intent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

mHealth self-help + varenicline

Active Comparator group

Description:

Participants in this control arm received standard cognitive-behavioral self-help materials delivered via a mobile health (mHealth) program + a standard course of varenicline.

Treatment:

Behavioral: Cognitive-behavioral self-help

Drug: Varenicline

mHealth MyMAP program + varenicline

Experimental group

Description:

Participants in the experimental arm received standard cognitive-behavioral self-help materials delivered via a mHealth program + additional personalized support features (automated, tailored advice managing nicotine withdrawal symptoms and medication side-effects \& secure messaging with a cessation counselor; i.e., MyMAP program) + a standard course of varenicline.

Treatment:

Behavioral: Cognitive-behavioral self-help

Drug: Varenicline

Behavioral: MyMAP (My Mobile Advice Program)